BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3090563 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11150
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE SHOWED NO ABNORMALITIES THAT COULD HAVE CAUSED THE REPORTED CONDITION. FUNCTIONAL TESTS WERE PERFORMED, SHOWING NO SIGNS OF NO FLOW. FLUID WAS ABLE TO FLOW THROUGH THE DEVICE AND THE DELIVERED DROP VOLUME MET THE SPECIFICATION RANGE. THE CAUSE WAS NOT IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK LUER ACTIVATED VALVE TO IV ACCESS HAD A SLOWER FLOW RATE COMPARED TO OTHERS USED. THE VALVE APPEARED TO BE LAZY/SLOW ON ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192855 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12G23110

    Patients

    Seq Age Sex Outcome Treatment
    1